CLAVERSAL ESPUMA RECTAL (Rectal Foam)

2. What you need to know before you start using Claversal rectal foam

Do not use Claversal

• if you are allergic to mesalazine or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to acetylsalicylic acid or any other salicylate
• if you have a medical condition that may make you prone to bleeding
• if you have severe kidney and/or liver impairment

Warnings and precautions

Talk to your doctor or pharmacist before you start using Claversal

• if you are or plan to become pregnant
• if you are breast-feeding
• if you have liver or kidney problems
• if you have any lung disease, such as asthma
• if you have been allergic to sulfasalazine in the past
• if you have a stomach or intestinal ulcer
• if you have previously had inflammation of the heart (which could be a consequence of a heart infection)
• if you have ever had a severe skin rash, blistering, or peeling after using mesalazine.

If you experience severe headache or recurrent headache, vision changes, or ringing or buzzing in the ears, contact your doctor immediately.

In case of appearance of any allergic manifestation (e.g., skin rash, itching) or fever during the course of treatment, do not apply more Claversal rectal foam and inform your doctor immediately.

Before and during treatment, your doctor may want to perform regular blood and urine tests to check the functioning of your liver, kidneys, blood, and lungs.

Kidney stones may occur with the use of mesalazine. The symptoms include pain in the sides of the abdomen and blood in the urine. Make sure to drink enough liquid during treatment with mesalazine.

Severe skin rashes, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (TEN), have been observed with mesalazine treatment. Stop taking mesalazine and seek immediate medical attention if you observe any of the symptoms related to these severe skin reactions described in section 4.

Mesalazine may cause a discoloration of the urine to a reddish-brown color after contact with sodium hypochlorite bleach in the toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Children and adolescents

The information on safety in the use of this medicine in children and adolescents is limited.

Do not administer to children under 5 years of age.

Other medicines and Claversal rectal foam

In general, you can continue treatment with other medicines while using Claversal. However, inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine, including those bought without a prescription.

Claversal may interact with other medicines if taken at the same time.

In particular:

• medicines to lower blood sugar (antidiabetics)
• medicines to lower blood pressure (antihypertensives/diuretics)
• medicines for the treatment or prevention of gout attacks
• medicines that help with bowel movements (laxatives containing lactulose)
• medicines to prevent blood clotting (anticoagulants)
• medicines to reduce the activity of the immune system (e.g., azathioprine, 6-mercaptopurine, or thioguanine)
• medicines to treat pain and inflammation (anti-inflammatory agents)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is limited experience with the use of mesalazine during pregnancy and breast-feeding. The newborn may develop allergic reactions after breast-feeding, such as diarrhea. If the newborn develops diarrhea, breast-feeding should be interrupted.

The use of Claversal is not recommended during pregnancy or breast-feeding unless your doctor advises you otherwise.

Driving and using machines

No adverse effects of Claversal on the ability to drive or use machines have been reported.

Claversal rectal foam containssodium metabisulfite, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and glycerol

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite.

This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

This medicine may cause a mild laxative effect because it contains glycerol.

This medicine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially sodium-free.

3. How to use Claversal rectal foam

Follow your doctor's instructions for using Claversal exactly, regarding the way and time of using the rectal foam; otherwise, you may not benefit fully from its effects.

In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Claversal rectal foam. Do not stop treatment before completion, even if you feel better, as symptoms may return if treatment is stopped too soon.

Strictly follow the treatment according to your doctor's instructions, both in the acute inflammatory phase and in the maintenance time established.

The recommended dose for an adult is:

One to two applications per day (1 to 2 g), for four to six weeks.

Use in children and adolescents

The administration of Claversal to children and adolescents under 18 years of age is not recommended due to the lack of safety and efficacy data.

Do not administer to children under 5 years of age.

Use in elderly patients

The use of Claversal in elderly patients should be done with caution and limited to those patients with normal renal function.

Claversal 1 g rectal foam is used rectally.

If you use more Claversal than you should

Talk to your doctor if you have used more than prescribed. In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to use Claversal

Do not use a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although severe allergic reactions are very rare. If you experience any of these symptoms after using this medicine, stop using this medicine and contact your doctor immediately:

• allergic skin rash;
• fever;
• difficulty breathing.

If you experience fever or irritation of the throat or mouth, stop using this medicine and contact your doctor immediately. These symptoms may be due, very rarely, to a decrease in the number of white blood cells in the blood (a condition called agranulocytosis).

Severe side effects:

Stop taking mesalazine and seek immediate medical attention if you experience any of the following symptoms:

• red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, generalized rash, fever, and swollen lymph nodes. These severe skin rashes are often preceded by fever or flu-like symptoms.
• if you experience severe headache or recurrent headache, vision changes, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension)

The following side effects have also been reported in patients using mesalazine:

Rare side effects(may affect up to 1 in 1,000 patients)

• abdominal pain, diarrhea, flatulence, nausea, and vomiting;
• headache, dizziness;
• chest pain, difficulty breathing, or swollen limbs due to an effect on the heart;
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

Very rare side effects(may affect less than 1 in 10,000 patients)

• kidney problems, sometimes with swollen limbs or side pain;

• severe abdominal pain due to acute pancreatitis;
• worsening of colitis symptoms;
• fever, sore throat, or nausea due to changes in blood count;

• difficulty breathing, cough, wheezing, spots on lung X-ray due to allergic and/or inflammatory conditions in the lungs;
• diarrhea and severe abdominal pain due to an allergic reaction to the medicine in the intestine;

• skin rash or inflammation;
• muscle and joint pain;
• jaundice or abdominal pain due to liver or biliary disorders;
• hair loss and development of baldness;
• erythema multiforme;
• numbness and tingling of the fingers and toes (peripheral neuropathy)
• reversible decrease in semen production;
• blood count disorders.

Side effects of unknown frequency(cannot be estimated from the available data).

• kidney stones and associated kidney pain (see also section 2).

Photosensitivity

More severe reactions have been reported in patients with pre-existing skin conditions, such as atopic dermatitis and atopic eczema.

If these symptoms continue or become more severe, talk to your doctor.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Claversal rectal foam

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

This pack is a pressurized aerosol that contains a flammable propellant. It should be kept away from any heat source, flames, or sparks, including cigarettes. It should be protected from direct sunlight and not destroyed or burned, even when empty.

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Claversal 1 g rectal foam

• The active ingredient is mesalazine (1g per application)
• The other ingredients (excipients) are: sorbitan monooleate, polysorbate 20, emulsifying wax, anhydrous colloidal silica, sodium metabisulfite (E-223), disodium edetate, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, glycerol, polyethylene glycol 300, purified water, propane, iso-butane, and n-butane.

Appearance of the product and pack contents

Rectal foam for administration. The foam is white to light brown in color.

The pack includes:

• 1 aerosol that dispenses 14 applications,
• a kit consisting of a base or grid with 14 compartments (containing a small amount of petroleum jelly), and 14 disposable applicators are inserted into these compartments. The purpose of the petroleum jelly is to facilitate the introduction of the applicators into the rectum,
• 14 disposable plastic bags,
• a patient information leaflet.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

SOFAR

Via Firenze, 40

20060 Trezzano Rosa, Milan

Italy

Date of last revision of this leaflet:January 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/